PEMBlog

OCTOBER 31, 2024

Why is this important for patients and caregivers ? Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. 2018 Nov 22;379(21):2002-2014.

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FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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FDA Law Blog

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

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IT Clinic Provider Patients 105

AMMD

FEBRUARY 14, 2025

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. This is why conventional physicians treat DCIS in patients with surgery, radiation, and sometimes chemotherapy. Some healthcare providers may recommend an MRI or ultrasound.

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Diagnosis Screening IT Patient-Centered 130

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).

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FDA Law Blog

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March. This should serve as a reminder to submitters to carefully review their MDRs ahead of submission.)

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FDA Law Blog

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions.

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BMJ

JULY 17, 2020

As previous research has found, providing factual information helps tremendously in addressing misconceptions and myths about infectious diseases, the latter of which can seriously undermine implementation of preventive measures. How to reduce the negative psychological impact MRSA isolation on patients. 2014 (28 August).

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FDA Law Blog

NOVEMBER 1, 2023

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).

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Medical Manufacturing Healthcare Government 75

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. In September 2014—nearly ten years ago!—PTE 351, 355-56 (1985). PTE applications were submitted to FDA for each of U.S.

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CDOCS

MARCH 26, 2021

png]<br /> <em><span style="font-size:11px;">​Figure& 1:& <span data-contrast="auto" xml:lang="EN-US">A life-long bruxer, this patient presented with lost teeth in the posterior and compensatory eruption of lower anterior teeth.</span>&

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FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Thus, it is wholly unrealistic for the Third-Party Review Program to provide any meaningful reduction in Agency workload. 2, 2014), [link]. [12]

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IT Medical Patient-Centered Provider 69

Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. ” Abstract/Full Text Copyright © 2025 HealthDay.

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Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

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Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. This requires emergency treatment.

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The Clinical Problem Solvers

MARCH 4, 2024

However, it is important to think about individual stories within the broader historical and sociocultural context; for instance, you cannot highlight stories in individual physician-patient dyads, without discussing mechanisms of racialized, historical, or sociocultural power and other larger structural forces. 2014 Feb;103:126-133.

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GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? This is back in, I don’t know, like 2014 maybe. And then one patient who really knew more about a topic than I did, which unfortunately happens much more often.

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Medical IT Patient-Centered Healthcare 100

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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Patient-Centered IT Healthcare Medical 96

GeriPal

JULY 21, 2022

Initially, it was just because there weren’t really answers for my patients. We’re going to go into how to talk to patients about this, because Emmy, you’ve done some research on it. Because to me, the cognitive concerns are the ones that the patient is not likely to self identify. Eric: Yeah.

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IT Families Family Diagnosis 102

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

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Families Family IT Patients 107

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

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Patient-Centered IT Hospital Patients 78

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. They can’t believe it, but we come back again and again and again gently to provide that support. And so the attitude has unfortunately become like, we just don’t provide care to folks.

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Healthcare IT Community Illness 102

PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2014 May;133(5):e1179-88. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. MMWR Recomm Rep. 2012 Jan 13;61(RR-1):1-20. PMID: 22237112. Pediatrics.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Available from: [link] Rice GM, Steiner RD.

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GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. And, of course, this is what families of patients undergoing palliative care go through. This is 24,000 encounters, over 15,000 patients, 11 hospitals, eight states.

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GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. I don’t see a lot of those out there. Randomized controlled trials of chaplaincy interventions.

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IT Patient-Centered Families Family 99

FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

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IT Provider ER Insurance 52

GeriPal

DECEMBER 7, 2023

Elders Climate Action, and let me just tell you a little bit about who we are, was created in 2014 as the project of a 501(c)(3), Elders Action Network. What do we do to very concretely provide heat shelters and cool shelters? Leslie: Well, yes, thank you, Ruth. One is AirNow from the EPA that you can have on your smartphone.

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Healthcare IT Education Hospital 130

BMJ

JUNE 25, 2021

9 The availability of electronic health records makes it easier to follow up on patients’ health information for an extended period. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time. and the prediction window at 5 years. 16 Figure 1. www.statisticsauthority.gov.uk/assessment/code-of-practice

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BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2021-001143 The COVID-19 pandemic has resulted in profound changes in patient and prescriber behaviour. In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions.

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Physician's Weekly

JUNE 17, 2025

And like the Tennants, many patients find themselves stuck in a convoluted appeals process marked by long wait times, frustrating customer service encounters, and decisions by medical professionals they’ve never met who may lack relevant training. For most patients, though, the process works seamlessly.

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PEMBlog

MAY 9, 2024

Nat Genet 2014; 46:1274. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. A pediatric neurologist.

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